First-ever WHO prequalification for China vaccine firm

More than four billion people live in JE-endemic regions in South East Asia and the Western Pacific. JE is carried by mosquitoes and causes a viral brain infection. It is the leading cause of viral neurological disease and disability in Asia, with nearly 70,000 cases and an estimated 10,000 to 15,000 deaths reported each year.

However, because of limited surveillance and complexities in diagnosis, these figures likely underestimate JE’s impact. Children who survive JE are often left with severe neurological damage. “We have reached two major milestones today. In addition to achieving WHO prequalification of our JE vaccine, we are proud to be the first Chinese manufacturer to produce a WHO-prequalified vaccine,” said Dr YANG Xiaoming, CEO of CNBG.

“As one of the largest vaccine manufacturers in the world, we take our mission of providing safe, effective, and affordable vaccines very seriously. With PATH’s support and WHO’s prequalification, we’re proud to bring China onto the global stage as an important vaccine supplier serving GAVI-eligible countries.” Over the past decade, PATH has led a cross-sector collaboration with CNBG, CDIBP, and other global partners to pave the way for the prequalified JE vaccine—improving surveillance systems to better understand the disease burden; identifying the existing SA 14-14-2 live, attenuated JE vaccine and working to scale it up; collaborating on clinical trials; and helping countries plan for vaccine introduction.

PATH worked with CDIBP to construct a new manufacturing facility that would meet rigorous international standards for vaccine quality and good manufacturing practices while ensuring adequate supply. PATH also negotiated with CDIBP to establish an affordable public-sector price and supported vaccination campaigns in 11 countries outside of China that have already licensed or registered the vaccine for use ahead of WHO prequalification. Those campaigns have reached more than 200 million people to date.

“Today’s prequalification means that all communities in JE regions will have access to a safe, affordable vaccine,” said Dr. Kathleen Neuzil, director of PATH’s Vaccine Access and Delivery Global Program. “We’ll now work with our global health and in-country partners to accelerate the delivery of this vaccine to children in low-resource settings who are most vulnerable to the disease and its severe consequences.”

PATH also leads a multicountry JE project that is taking a regional approach to the adoption, introduction, and scale-up of JE vaccination in endemic countries, building on the lessons learned and best practices developed over the past decade.